Acupuncture for Non-cyclical Breast Pain

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275574
First received: January 10, 2006
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

Breast pain or mastalgia is a common and troublesome symptom for many women. Whereas cyclical breast pain related to hormonal fluctuations can frequently be treated, non-cyclical breast pain can go untreated due to its various etiologies and non-specific presentation. Acupuncture is an ancient form of Chinese medicine that has been used for centuries to treat a vast array of illnesses and conditions. Research has shown that acupuncture has a link to a release of endorphins and other chemicals in the central nervous system. Thus, it is thought to help relieve pain. To date, there has been minimal research using acupuncture for breast pain. This pilot of 30 women will seek to determine whether four acupuncture treatments over a period of two weeks will significantly lower the level of pain experienced by these participants. Additionally, we will evaluate quality of life measures.


Condition Intervention
Breast Pain
Procedure: acupuncture

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture for the Treatment of Non-Cyclical Breast Pain

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Four acupuncture treatments over a period of two weeks can improve non-cyclical breast pain [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: April 2003
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: acupuncture
    acupuncture
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • Female
  • greater than 18 years
  • non-cyclical unilateral or bilateral breast pain occurring daily, Greater than or equal to 2 on the BPI (average pain question)
  • pain for more than 3 months
  • satisfactory (non-suspicious for malignancy) breast examination within one year of enrollment (need documentation from physician or advanced practice nurse)
  • satisfactory (non-suspicious for malignancy) mammogram and/or ultrasound within one year if Greater than 35 years(need written report to verify)
  • able to return for acupuncture two times a week for two weeks
  • speak and understand English
  • hormone replacement therapy discontinued > 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275574

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Lori A. Thicke, R.N., M.S. Mayo Clinic
  More Information

No publications provided

Responsible Party: Lori A Thicke, R.N., M.S., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275574     History of Changes
Other Study ID Numbers: 1975-02
Study First Received: January 10, 2006
Last Updated: December 13, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mastodynia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014